AXIV ALLERGY- diphenhydramine hydrochloride capsule, liquid filled

AXIV Allergy by

Drug Labeling and Warnings

AXIV Allergy by is a Otc medication manufactured, distributed, or labeled by VIVUNT PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active Ingredient (in each softgel): Purpose
• Diphenhydramine HCl 25 mg: Antihistamine

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat
• temporarily relieves these symptoms due to the common cold:
• runny nose
• sneezing

Warnings

Do not use

• to make a child sleepy
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Keep out of reach of children

Keep out of reach of children.

If pregnant or breast-feeding

ask a health professional before use.

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

• Take every 4 to 6 hours, or as directed by a doctor
• Do not take more than 12 Softgels in 24 hours for Adults and children 12 years and over. Do not take more than 6 Softgels for children 6 to under 12 years of age in 24 hours.

• adults and children 12 years and over: 1 or 2 Softgels
• children 6 to under 12 years: 1 Softgel
• children under 6 years: do not use

Other information

• Store at 20° - 25 °C (68 °- 77 °F)
• Read all product information before using
• Tamper Evident: Do not use if the foil printed on the blister is torn or ripped.
• Tamper Evident: Do not use if carton or pouch is open

Inactive ingredients

Gelatin, Glycerin, Methylparaben, Polyethylene Glycol 400, Propylparaben, Purified Water, Sorbitol, Titanium Dioxide

PRINCIPAL DISPLAY PANEL 24

Compare to Benadryl® Allergy Liqui-Gels®

active ingredients*

NDC: 82706-019-01

AXIV Antihistamine

• Runny Nose
• Sneezing
• Itchy, Watery Eyes
• Itchy Throat

DYE-FREE

Diphenhydramine HCl

24 SOFTGELS** **Liquid-filled capsules

INGREDIENTS AND APPEARANCE

AXIV ALLERGY 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82706-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GELATIN (UNII: 2G86QN327L)
METHYLPARABEN (UNII: A2I8C7HI9T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (Transparent)	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	AXIV
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82706-019-01	2 in 1 CARTON	03/08/2024
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 82706-019-02	3 in 1 CARTON	03/08/2024	03/09/2024
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/08/2024

Labeler - VIVUNT PHARMA LLC (045829437)